MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. HYDROSITE AG GENTLE 10CM CTN 10; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66801381

Device Problems Material Discolored (1170); Defective Device (2588); Material Integrity Problem (2978)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2020

Event Type  Injury  

Event Description

It was reported that when the hydrosite ag pouch was opened, it was confirmed the 5 dressings were grayish, so they were not used for treatment.Because there was no backup dressing, a piece of gauze was temporally applied to the wound until the customer received the backup.No patient harm.No delay was reported.The samples will be returned for investigation.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

We have now concluded our investigation into this complaint.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.A complaints history review was carried out using the lot and part numbers provided, there have been further complaints reported with this failure mode in the past three years.A risk management review was carried out.Discoloration is not a harm or failure mode.The devices intended for use in treatment were returned.The returned devices were visually inspected and found they turned grayish, which establishes a relationship between the device and the reported event.It is the inherent characteristic of polyurethane to change color after sterilization and a period of storage.It should be noted that the dressing performance will not be impacted by the color change.This has been verified by the stability study.A clinical investigation was carried out.It was concluded: "a review of this complaint case revealed there were no patient injuries reported.Per report, the hydrosite ag pouch dressings were not used for treatment.Since no adverse events are being reported, no further medical assessment is warranted." no further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: HYDROSITE AG GENTLE 10CM CTN 10
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10726557
• MDR Text Key: 212724261
• Report Number: 8043484-2020-03272
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 04582111153449
• UDI-Public: 4582111153449
• Combination Product (y/n): N
• PMA/PMN Number: K142979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Catalogue Number: 66801381
• Device Lot Number: 201816
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 11/26/2020
• Supplement Dates FDA Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention